Protocol for Alpha MSH Infusion Study in Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— a-MSH & T2DM  

Official title:

Randomized Cross-over Designed Study of the Physiological Impact of Alpha MSH on Glycemic Response to an Oral Glucose Tolerance Test in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06293664
• Other study ID #: RAHM-2023-006
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: April 4, 2024

Study information

• Verified date: February 2024
• Source: Dasman Diabetes Institute
• Contact: Ebaa Al Ozairi, MD
• Phone: (+965) 22242999
• Email: ebaa.alozairi[@]dasmaninstitute.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alpha-melanocyte stimulatory hormone (α-MSH) is a melanocyte-stimulating hormone produced by the hypothalamus and released from the pituitary gland. It acts as an agonist to the melanocortin 5 receptor (MC5R) in human skeletal muscle, playing a role in glucose uptake and disposal. This study aims to investigate whether α-MSH can enhance glucose tolerance in patients with Type 2 Diabetes Mellitus (T2DM).

Description:

Pre-clinical studies in mice have shown improved glucose clearance with α-MSH infusion, particularly in skeletal muscle. Research has demonstrated that α-MSH improves glucose tolerance in healthy humans by promoting glucose uptake in skeletal muscle cells.

Therefore this study seeks to answer the question of whether alpha-MSH improves glucose tolerance in patients with T2DM. This will be addressed through measuring the impact of α-MSH infusion in patients with T2DM. The research involves a double-blinded, randomized, placebo-controlled crossover study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: April 4, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• People with T2DM treated with oral or injectable medications which have been stable for 3 months, but not insulin therapy for type 2 diabetes.

• Stable body weight and HbA1c for at least 3 months

• The participant is capable of giving written informed consent

• The participant is able to read, comprehend and record information written in English

Exclusion Criteria:

• Previous or current psychiatric diagnosis listed in DSM-V Axis 1.

• Significant current or past medical or psychiatric history that, in the opinion of the investigators, contraindicates their participation.

• History of type 1 diabetes mellitus.

• History of endocrine disorder.

• History of ischaemic heart disease, hypertension (current BP > 160/95 mmHg), heart failure, cardiac arrhythmia, peripheral vascular or cerebrovascular disease.

• History or presence of significant respiratory, gastrointestinal, hepatic, oncological, neurological or renal disease or other condition that in the opinion of the Investigators may affect participant safety or outcome measures.

• Unwillingness or inability to follow the procedures outlined in the protocol.

• History of sensitivity to any of the peptides, or components thereof, or a history of drug or other allergy that, in the opinion of the investigators, contraindicates their participation.

• Use of current regular prescription or over-the-counter medications that in the opinion of the Investigators may affect participant safety or outcome measures.

• Clinically significant abnormalities in screening electrocardiogram (ECG) or blood tests abnormalities which in the opinion of the study physician, is clinically significant and represents a safety risk.

• Current pregnancy or breast-feeding in female participants (the investigators would advise using contraception for the duration of the study).

• Pulse rate <40 or >100 beats per minute OR systolic blood pressure >160 and <100 and a diastolic blood pressure >95 and <50 in the semi-supine position.

• The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first experimental visit in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

• Exposure to more than 3 new investigational medicinal products within 12 months prior to the screening.

• Participants who have donated, or intend to donate, blood within three months before the screening visit or following study visit completion.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• a-MSH infusion
Pharmaceutical grade a-MSH is custom synthesized to GMP standards by Auspep (Australia www.auspep.com.au), a good manufacturing practice (GMP) accredited manufacturer of peptides, approved by the Therapeutic Goods Administration (TGA), European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA).
• Placebo solutions
Pharmaceutical GMP-grade sterile 0.5% human albumin dissolved in saline.

Locations

Country	Name	City	State
Kuwait	Dasman Diabetes Institute	Kuwait City

Sponsors (1)

Lead Sponsor	Collaborator
Dasman Diabetes Institute

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in energy intake measured by an ad libitum meal test at the saline vs. a-MSH infusion		12 months
Other	Adverse events (including flushing)		12 months
Primary	Difference in the total or incremental area under the curve of glucose and insulin concentration at an OGTT during saline vs. a-MSH infusion		12 months
Secondary	Difference in the total or incremental area under the curve of the concentration of metabolites (C-peptide, Glucagon, Gut hormones, a-MSH) during OGTT with saline or a-MSH infusion.		12 months